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Comparison of Commercial ELISA Kits to Confirm the Absence of Transmission in Malaria Elimination Settings

机译:商业ELISA试剂盒的比较证实疟疾消除环境中缺失的缺失

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Background Antimalarial antibody measurements are useful because they reflect historical and recent exposure to malaria. As such, they may provide additional information to assess ongoing transmission in low endemic or pre-elimination settings where cases are rare. In addition, the absence of antibody responses in certain individuals can indicate the cessation of transmission. Commercial malaria enzyme-linked immunosorbent assays (ELISA) detect antimalarial antibodies and are commonly used to screen blood donations for possible malaria infection. However, there is no standardised test to detect antimalarial antibodies for epidemiological use. Here we compared five commercially available ELISA kits (Trinity Biotech, newbio, DiaPro, Cellabs and NovaTec) in search of a standardised tool for supporting claims of absence of malaria transmission. For comparison, a research-based (RB) ELISA protocol was performed alongside the commercial kits. Results The commercial kits were first compared using serum samples from known malaria-unexposed individuals (n=223) and Toxoplasma-infected individuals (n=191) to assess specificity and cross-reactivity against non-malaria infections. In addition, 134 samples from ≥10-year-olds collected in a hyperendemic region in the Gambia in the early 1990s were used to assess sensitivity. Three out of five kits showed high sensitivity (90-92%), high specificity (98-99%), low cross-reactivity (0-3%) and were considered user-friendly (Trinity Biotech, newbio and NovaTec). Two of these kits (Trinity Biotech and NovaTec) were taken forward for epidemiological evaluation and results were compared to those using the RB-ELISA. Samples from two pre-elimination settings (Praia, Cape Verde; n=1,396, and Bataan, the Philippines; n=1,824) were tested. Serological results from both the Trinity Biotech kit and the RB-ELISA concurred with recent passively detected case counts in both settings. Results from the Trinity Biotech kit reflected a significant decrease in the number of reported cases in Bataan in the 1990s better than the RB-ELISA. Results from the NovaTec kit did not reflect transmission patterns in either setting. Conclusion The Trinity Biotech commercial ELISA kit was considered reliable for epidemiological use and accurately described transmission patterns in two (previously) malaria endemic settings. The use of this simple and standardised serological tool may aid national control and elimination programs by confirming that regions are free from malaria.
机译:背景技术抗疟疾抗体测量是有用的,因为它们反映了历史和最近暴露于疟疾。因此,它们可以提供额外的信息,以评估低流行或预先消除设置中的持续传输,其中壳体罕见。此外,某些个体中没有抗体反应可以表明传播的停止。商业疟疾酶联免疫吸附试验(ELISA)检测抗疟抗体,通常用于筛选血液捐献以进行可能的疟疾感染。然而,没有标准化测试以检测用于流行病学使用的抗疟疾抗体。在这里,我们将五种商用的ELISA试剂盒(Trinity Biotech,NewBio,Dio,Cellabs和NovaTec)进行了比较,寻找标准化的工具,用于支持缺乏疟疾传播的权利要求。为了比较,基于研究的(RB)ELISA协议与商业套件一起进行。结果首先使用来自已知的疟疾 - 未曝光的个体(n = 223)和毒素感染的个体(n = 191)的血清样品进行比较,以评估对非疟疾感染的特异性和交叉反应性。此外,在20世纪90年代初期在冈比亚的高级血症地区收集了134个来自≥10岁的样本,用于评估敏感性。五种试剂盒中的三个含量高,敏感度高(90-92%),特异性高(98-99%),交叉反应性低(0-3%),被认为是用户友好的(三位一体生物技术,Newbio和Novatec)。这些套件中的两种套件(三位一体生物技术和NovaTec)被提出了流行病学评估,结果与使用RB-ELISA的结果进行了比较。从两个预先消除设置(Praia,Cape Verde; n = 1,396和Bataan,菲律宾)的样本进行了测试。 Trinity Biotech试剂盒的血清学结果和RB-ELISA在两个设置中都有近期被动检测的案例计数。 Trinity Biotech Kit的结果反映了1990年代比RB-ELISA在20世纪90年代的报告病例数量的显着降低。 NovaTec Kit的结果没有反映任何一个设置中的传输模式。结论Trinity Biotech商业ELISA试剂盒被认为是可靠的流行病学使用,并准确地描述了两种(先前)疟疾流动环境的传输模式。使用这种简单和标准化的血清学工具可以通过确认地区没有疟疾,援助国家控制和消除计划。
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